Patients with questions regarding this recall can contact Pfizer Medical Information at 1-80 (Monday to Thursday 9am to 8pm ET or Friday, 9am to 5pm ET). Discontinuations due to adverse events were 15 versus 14 for venlafaxine ER and placebo, respectively, in older adults compared with 15 versus 8, respectively, for younger adults. Patients with questions regarding the return of product should contact Stericycle at 1-88 (Monday to Friday 8am to 5pm ET). Patients with affected product should notify their physicians and/or return product to their pharmacies.
#Venlafaxine er trial
Efficacy of venlafaxine in MDD was shown in both short-term trials and a longer-term trial in MDD see Clinical Studies (14.1). RECOMMENDATION: Pharmacists should immediately quarantine, discontinue distribution of and return all recalled lots of these products, as well as notify any of their customers to whom they distributed the products. Venlafaxine extended-release tablets are indicated for the treatment of major depressive disorder (MDD). Effexor half-life of the immediate-release formulation is five hours. Venlafaxine HCL ER has fewer side effects than the brand name however, it has no advantage over immediate-release formulation in reducing Effexor withdrawal effects. These direct customers are being notified by UPS next day mail, and Pfizer is arranging for the return of all recalled products. Venlafaxine ER 150 mg (or other strengths) is an extended-release drug formulation. This recall is to the patient level and involves Pfizer lot numbers V130142 and V130140, which both expire in October 2015, and Greenstone lot number V130014, which expires in August 2015.īACKGROUND: These products were distributed nationally to wholesalers, distributors, certain government agencies, patient assistance programs and retailers, such as pharmacies and hospitals. The use of Tikosyn by an Effexor XR/Venlafaxine HCl patient, where the contraindications and drug-drug interactions with Tikosyn have not been considered by the prescribing physician, could cause serious adverse health consequences that could be fatal. This action is being taken because of a pharmacist report that one bottle of Pfizer’s Effexor XR contained one capsule of Tikosyn (dofetilide) 0.25mg in addition to the Effexor XR capsules. issued a voluntary recall of one lot of 30-count Effexor XR (venlafaxine HCl) 150 mg extended-release capsules, one lot of 90-count Effexor XR (venlafaxine HCl) 150 mg extended-release capsules, and one lot of 90-count Greenstone LLC-branded Venlafaxine HC1 150 mg extended-release capsules. Effexor XR 150 Mg Extended-Release Capsules (Pfizer) and Venlafaxine HCl 150 Mg Extended-Release Capsules (Greenstone): Recall – Possible Presence of Tikosyn CapsulesĪUDIENCE: Pharmacy, Psychiatry, Family Practice Please see the link at the bottom of this blog for additional information. Since many of my patients are on this antidepressant, I am posting the FDA warning issued this morning.
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